A Study of Maribavir in Adults and Children With Post-transplant Cytomegalovirus (CMV) Infection in Argentina

Takeda

Status: Enrolling

Conditions: Cytomegalovirus (CMV)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06213974

TAK-620-4008

Details and patient eligibility

About

The main aim of this study is to learn about the safety of Maribavir in adults and children with post-transplant CMV infection in routine clinical practice in Argentina.

The other aim is to study the effectiveness of the treatment with Maribavir in routine clinical practice in Argentina.

Participants will be treated by their doctors according to normal medical practice. Study data will be collected either from information already available in the medical records or during study conduct.

Enrollment: 10 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Adult participants (18 years or older) and pediatric participants (12 years of age and older and weighing at least 35 kilogram [kg]) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet in the real-world setting of common clinical practice in Argentina.
• Have received at least one dose of maribavir according to approved indications.
• Have signed the mandatory informed consent/assent that has been agreed with national regulatory authorities (ANMAT) as applicable.

Exclusion Criteria

• There are no specific exclusion criteria.

Trial design

10 participants in 1 patient group

All Participants

Description:

Participants who have received maribavir treatment for the approved indication after marketing authorization (de novo participants) and before marketing authorization (legacy participants) under expanded access type of program or compassionate use in the real-world setting. Data will be collected prospectively and/or retrospectively from the medical records during this observational period of 16 weeks.

Treatment:

Other: No Intervention